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Monoclonal Antibodies

Isatuximab for Monoclonal Gammopathy

Phase 2
Recruiting
Led By Divaya Bhutani, MD
Research Sponsored by Columbia University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Renal biopsy proven diagnosis of an MGRS disorder including the following: Proliferative glomerulonephritis with monoclonal immunoglobulin deposits (PGNMID), C3 glomerulopathy associated with monoclonal gammopathy, Non-Amyloid Fibrillary Glomerulonephritis, Light chain Proximal Tubulopathy, Immunotactoid Glomerulopathy
Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months
Awards & highlights

Study Summary

This trial will test whether isatuximab can help improve kidney function in people with MGRS. Isatuximab is not approved by the FDA to treat MGRS, so this trial is considered 'investigational'.

Who is the study for?
Adults over 18 with MGRS, a kidney condition linked to abnormal proteins in the blood. They should have a life expectancy over 6 months, be relatively active (ECOG ≤2), and have normal organ/marrow function. Those previously treated for MGRS can join if they haven't used CD38 antibody therapy or had certain treatments within the last 3-6 months.Check my eligibility
What is being tested?
The trial is testing Isatuximab's effectiveness on improving kidney function in MGRS patients. Although FDA-approved for multiple myeloma, its use here is investigational as it's not yet approved for treating MGRS.See study design
What are the potential side effects?
Possible side effects of Isatuximab include allergic reactions similar to those from drugs with similar makeup, which could range from mild skin reactions to severe anaphylaxis.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a kidney condition diagnosed through a biopsy, related to abnormal protein deposits.
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I can take care of myself and perform daily activities.
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My kidney disease is linked to abnormal protein in my blood.
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I have been diagnosed with a kidney condition involving abnormal protein deposits.
Select...
My blood tests show normal organ function and I meet the required levels for white blood cells, platelets, liver enzymes, and kidney function.
Select...
I have been diagnosed with a kidney condition that is not caused by amyloid proteins.
Select...
My kidney disease was confirmed by a biopsy to be an MGRS disorder.
Select...
I have a kidney condition related to abnormal protein deposits.
Select...
I have been diagnosed with Immunotactoid Glomerulopathy.
Select...
I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall Renal Response Rate
Secondary outcome measures
Number of Adverse Events
Percentage of Participants with Immunoglobulin Gene Mutations

Side effects data

From 2023 Phase 3 trial • 307 Patients • NCT02990338
35%
Neutropenia
21%
Fatigue
21%
Diarrhoea
21%
Pneumonia
20%
Constipation
19%
Asthenia
19%
Upper Respiratory Tract Infection
16%
Back Pain
13%
Pyrexia
12%
Oedema Peripheral
12%
Arthralgia
11%
Bronchitis
11%
Thrombocytopenia
11%
Muscle Spasms
9%
Dyspnoea
9%
Nausea
9%
Insomnia
9%
Urinary Tract Infection
9%
Bone Pain
7%
Cough
7%
Cataract
7%
Nasopharyngitis
7%
Peripheral Sensory Neuropathy
7%
Pruritus
6%
Headache
6%
Fall
5%
Muscular Weakness
5%
Decreased Appetite
5%
Hypertension
5%
Tremor
5%
Musculoskeletal Chest Pain
5%
Disease Progression
5%
Rash
4%
Vomiting
4%
Acute Kidney Injury
4%
Influenza
4%
Abdominal Pain
3%
Myalgia
3%
Pathological Fracture
3%
Pain In Extremity
3%
Pneumocystis Jirovecii Pneumonia
3%
Febrile Neutropenia
3%
Oropharyngeal Pain
3%
Septic Shock
3%
Dizziness
3%
Stomatitis
2%
Lower Respiratory Tract Infection
2%
Renal Failure
2%
Hypercalcaemia
2%
Oral Herpes
2%
Productive Cough
2%
General Physical Health Deterioration
2%
Lung Infection
1%
Renal Aneurysm
1%
Diabetic Ulcer
1%
Spinal Compression Fracture
1%
Orthostatic Hypotension
1%
Malnutrition
1%
Respiratory Tract Infection
1%
Confusional State
1%
Cerebral Haemorrhage
1%
Haemorrhage Intracranial
1%
Atrial Fibrillation
1%
Tumour Associated Fever
1%
Hyponatraemia
1%
Cauda Equina Syndrome
1%
Angina Pectoris
1%
Cardiac Failure
1%
Covid-19 Pneumonia
1%
Syncope
1%
Pancreatitis Acute
1%
Sudden Death
1%
Cytomegalovirus Gastrointestinal Infection
1%
Infusion Related Reaction
1%
Candida Pneumonia
1%
Pneumonia Fungal
1%
Basal Cell Carcinoma
1%
Diverticulitis
1%
Escherichia Sepsis
1%
Gastroenteritis
1%
Anaemia
1%
Dehydration
1%
Ischaemic Stroke
1%
Pleural Effusion
1%
Pulmonary Embolism
1%
Pulmonary Oedema
1%
Respiratory Failure
1%
Death
1%
Accidental Overdose
1%
Pneumonia Bacterial
1%
Pyelonephritis
1%
Pyelonephritis Acute
1%
Sepsis
1%
Sinusitis
1%
Hyperviscosity Syndrome
1%
Pancytopenia
1%
Femur Fracture
1%
Pneumonia Haemophilus
1%
Pneumonia Influenzal
1%
Pneumonia Streptococcal
1%
Bronchospasm
1%
Large Intestine Perforation
1%
Weight Decreased
1%
Covid-19
1%
Infection
1%
Presyncope
1%
Spinal Subdural Haematoma
1%
Retinal Detachment
1%
Vision Blurred
1%
Myocardial Infarction
1%
Deep Vein Thrombosis
1%
Ataxia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pd (Pomalidomide + Dexamethasone)
IPd (Isatuximab + Pomalidomide + Dexamethasone)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Isatuximab for MGRSExperimental Treatment1 Intervention
Subjects will receive Isatuximab for 6 months and will be followed for an additional one year post therapy for outcome follow-up.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Isatuximab
2016
Completed Phase 3
~370

Find a Location

Who is running the clinical trial?

Genzyme, a Sanofi CompanyIndustry Sponsor
524 Previous Clinical Trials
85,603 Total Patients Enrolled
Columbia UniversityLead Sponsor
1,432 Previous Clinical Trials
2,460,946 Total Patients Enrolled
Divaya Bhutani, MDPrincipal InvestigatorAssistant Professor of Medicine at the Columbia University

Media Library

Isatuximab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04614558 — Phase 2
Isatuximab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04614558 — Phase 2
Monoclonal Gammopathy Research Study Groups: Isatuximab for MGRS
Monoclonal Gammopathy Clinical Trial 2023: Isatuximab Highlights & Side Effects. Trial Name: NCT04614558 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current participant count for this clinical study?

"A total of 27 participants, who meet the eligibility criteria, are required for this research endeavour. The study is currently recruiting from multiple locations including Columbia University Irving Medical Centre in New york City and Pennsylvania’s own University of Philadelphia."

Answered by AI

Are there still openings for enrollees in this research project?

"Affirmative. According to clinicaltrials.gov, this investigation has been actively recruiting since June 8th 2021 and the deadline is November 16th 2022; 27 participants are needed from 3 different sites."

Answered by AI

Are there any dangerous side effects associated with Isatuximab treatments?

"Isatuximab was assigned a score of two on our safety scale, as the phase 2 clinical trial did not give evidence for efficacy but does provide some data demonstrating its security."

Answered by AI

Has this exploration been undertaken before?

"Presently, Isatuximab is being tested in 46 live studies across 39 nations and 358 cities. Sanofi initiated the first trial for this medication back in 2010; it involved 351 participants and concluded its Phase 1 & 2 testing process successfully. To date, 5 trials have been finalized since then."

Answered by AI

Have there been any other investigations involving Isatuximab in the past?

"Isatuximab was initially tested in 2010 at the 604001 research facility. Since then, 5 clinical trials have been accomplished, and there are currently 46 being conducted with a focus on New york City."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Isatuximab in Patients With Monoclonal Gammopathy of Renal Significance
Divaya Bhutani 2021. "Isatuximab in Patients With Monoclonal Gammopathy of Renal Significance". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04614558.
~7 spots leftby Apr 2025
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